Initial Efficacy Study of a Phytoestrogen Vaginal Cream (VagRenew™) for the Treatment of Menopausal Symptoms

David D. Moon, D.O.
Private Practitioner, Las Vegas, NV

Introduction

Menopause will affect over 67 million women in the United States within the next ten years. The aging of our population will signal a shift in women over the age of 50 accounting for over 30% of our population. While many women suffer no ill effects from the transition through menopause, as many as 65% complain of pelvic symptoms (vaginal dryness, soreness, and pain with intercourse). The treatment of these symptoms has largely consisted of hormone replacement therapy (HRT). Recently, due to concerns about the safety of HRT, many women have sought natural alternatives for their menopausal complaints. The majority of the alternative medicine products on the market have no basis in medical research, and no evidence of their efficacy exists (beyond anecdotal reports). Using evidence-based medicine and the reported binding affinities for the compounds in soy isoflavones (phytoestrogens), a vaginal cream was developed to have similar local effects to estradiol 0.01% vaginal cream.

Materials and Methods

From April through July 2006, fourteen patients with an average age of 51 (range 40-71) used VagRenew™ for one month and filled out questionnaires regarding symptoms and their severity both pre- and post-treatment. The severity of symptoms was graded on an analog scale (1 to 10) with a higher number associated with a more severe symptom.

Results

Vaginal dryness improved in 100% of patients (7/7) with a mean pre-treatment score of 5.3 (range 2-10) and a mean post-treatment score of 1.3 (range 0 – 4). Urinary frequency and urgency improved in 89% of patients (8/9) with a mean pre-treatment score of 4.1 (range 1-10) and a mean post-treatment score of 1.2 (range 0-7). Painful intercourse improved in 86% of patients (6/7) with a mean pre-treatment score of 6.9 (range 1-10) and a mean post-treatment score of 1.3 (range 0-4). Pelvic pain improved in 86% of patients (6/7) with a mean pre-treatment score of 5.7 (range 1-10) and a mean post-treatment score of 2.3 (range 0-6). Hot flashes improved in 57% of patients (8/14) with a mean pre-treatment score of 7.2 (range 3-10) and a mean post-treatment score of 5.1 (range 0-10). 93% (13/14) of patients reported help with at least one of their symptoms of menopause.

Conclusions

VagRenew™ is an effective treatment option for menopausal women suffering from the pelvic complaints of menopause, including vaginal dryness, pelvic pain, urinary frequency and pain with intercourse. While some improvement was seen with vasomotor symptoms, the results were not as dramatic, and complementary therapy may be indicated.